MAUDE Adverse Event Report: ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle Weakness (1967)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation at the manufacturing site.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing site.

Event Description

On 15dec2022 anika received a medwatch report (mw5113703) from the fda.The patient was asked "since your last refill, have you been hospitalized?" the patient stated "yes, went to the emergency room with weakness in the left hand".Patient was admitted for observation overnight, diagnosed with possible tia (transient ischemic attack) or peripheral nerve damage.The patient was not experiencing any problems at the time and there was no further information obtained.Patient received an orthovisc injection (procedure was not reported on an unspecified date).There is no specific allegation in the description of the event of an adverse event or malfunction with the orthovisc injection or syringe.The lot number and catalog number were not provided.Contact information was not provided.It is unknown who treated the patient.There was no report of any device malfunction referenced in the report.The current status of the patient is unknown at this time.Anika has reached out to the distributor and this case was not on file.

Manufacturer Narrative

This case is still under investigation at the manufacturing site.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing site.Additional information the reported issue was not confirmed.The patient reported being hospitalized after receiving an orthovisc injection on an unspecified date.The clinic name and location was not provided.The patient reported weakness in the left hand and was admitted to the hospital for observation for one night.The patient was reportedly diagnosed with possible tia (transient ischemic attack) or peripheral nerve damage.The patient was not experiencing any problems at the time of the orthovisc injection and there was no further information obtained.The lot number was not provided.There was no report of any device malfunction or any unusual appearance with the packaging or device at the time of use.The current status of the patient is unknown.Clinical review of the case details determined that there is insufficient information to determine an association between the intra-injection and the reported complaint.Insufficient information about patient demographics, pre-existing medical history, as well as unknown temporal association of the intra-injection and the complaint.A review of the lots batch record was not performed as the lot number was not provided.All product manufactured by anika and anika entities are released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.

Event Description

On 15dec2022 anika received a medwatch report (mw5113703) from the fda.The patient was asked "since your last refill, have you been hospitalized?" the patient stated "yes, went to the emergency room with weakness in the left hand." patient was admitted for observation overnight, diagnosed with possible tia (transient ischemic attack) or peripheral nerve damage.The patient was not experiencing any problems at the time and there was no further information obtained.Patient received an orthovisc injection (procedure was not reported on an unspecified date).There is no specific allegation in the description of the event of an adverse event or malfunction with the orthovisc injection or syringe.The lot number and catalog number were not provided.Contact information was not provided.It is unknown who treated the patient.There was no report of any device malfunction referenced in the report.The current status of the patient is unknown at this time.Anika has reached out to the distributior and this case was not on file.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: le van ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 16102560
• MDR Text Key: 306703484
• Report Number: 3007093114-2023-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 81 MG ASPIRIN; 81 MG ASPIRIN; PLAVIX UNKNOWN DOSAGE; PLAVIX UNKNOWN DOSAGE
• Patient Outcome(s): Hospitalization